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It is believed to be an appropriate way to address the other problems identified with Woodcock and the drug testing pipeline. In fact, this week Woodcock FDA has released a huge set of news instructions for creating more of these master protocols.
None of them solves an urgent problem: time. It will be difficult for any of these studies to register Covid patients. “It is the nature of a pandemic, it will have peaks and troughs at different times and places in the world. Right now our biggest selectors, you won’t be surprised, are in India, ”says Gordon of Remap-Cape.“ Now, they’re not as well prepared for research as the UK and the US; so their number of hires is much less than we hired in the UK, even though their number is higher. ”
Vaccines will never completely eradicate Covid-19. In available countries, some refuse to take it; some countries cannot afford them. So good Covid drugs are still important. However, these rehearsals feel a bit late. “The concept is great. The concept a year ago would have been even better, “says David Boulware, an infectious disease physician and researcher at the University of Minnesota School of Medicine, who is involved in Activ-6 and other tests at Covid. Don’t say delay until science, says the policy .
Woodcock was in the FDA last year and worked in therapeutics as part of Operation Trump’s Operation Warp Speed. This program helped create vaccines that are now overcoming the pandemic, but the need for therapy was not so … urgent. “Of course, the previous administration wasn’t interested in the investigation, because by the end of last week, all of that was going to go away,” Boulware says, adapting to President Trump until then. unfounded optimism in the early days of the pandemic. “So really all of this happened after January 20, 2021.”
Wherever politics is an obstacle, so is money. (Like Carl Zimmer he wrote in The New York Times, last January the U.S. government spent about $ 18 billion on vaccine research and development and about $ 8 billion on therapeutics.) As always, however, pharmacy money does a lot to clear the way for the drug. Covid was a kind of first successful drug hunt remdesivir, A brilliant anti-virus made by the Gilead drug company; One from the US examination with the help of the company and the materials found in April 2020 it has been done to reduce the amount of time people have had symptoms; later studies including Union it has found no effect on survival.
But patent-free drugs don’t get the same money from pharmaceutical companies, so they don’t get the same corporate boost. The study of cheap medicines and reuse usually requires government funding. “A lot of them are generic drugs. So why aren’t these carried forward? Because there is no patent for the pharmaceutical company and therefore no profit. There’s no drug company saying, ‘We’re going to give you $ 10 million to look into that,’ “Boulware says.” So the government has to do it, and the government wants to do it. is ‘We’ve actually come up with some new drugs that we don’t have, but six months from now we’ll have enough to treat 10,000 people and it’ll cost $ 10,000 per dose.’ “
This leads to a broader view that Woodcock hopes to avoid the chaos of the low trial he hopes next pandemic: the main protocols that are more economical and effective for testing more than one medication at a time. “What was interesting about this pandemic is that if you look at all the therapeutic results, especially for immunomodulators, there is still a lot of back and forth today about what regimen should be used, and we have conflicting test results,” says Woodcock. “What this usually means is that there were small effects of treatment and the trials did not have the strength to provide a definitive response.” The large multi-arm and major protocol studies seek to narrow the gap between large drug companies that make large and expensive trials of expensive drugs and small idiosyncrasies that do not generate enough new knowledge. During the pandemic, there has been insufficient government-funded, ambitious, life-threatening system failure.
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